Technical Migration Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeClinicalDocument Full time €90,000 - €120,000

Clinical Document Management Lead

Job Description:

The Clinical Document Governance Management (CDGM) is responsible for developing and implementing strategies to enhance the management of clinical documents. This role involves leading the planning and execution of technical migrations, ensuring alignment with business, compliance, and operational requirements.

  • Lead the implementation of CDGM initiatives to improve the planning and execution of technical migrations.
  • Collaborate with stakeholders to identify and agree on migration business requirements, understand source and target system capabilities, and develop a future technical migration roadmap.
  • Manage activities related to migration-related Incident Management, Change Management, and ongoing operations of the electronic document management system.
  • Support the forecasting of internal resource allocations and vendor-provided activities as part of eDMS migration roadmap management.
  • Execute the vendor oversight plan, monitor service metrics, and identify opportunities for improvement.
  • Provide support for inspections/audits, contribute to root cause analysis, and creation/delivery of CAPAs.
Responsibilities:
  • Develop and implement strategies to enhance the management of clinical documents.
  • Lead the planning and execution of technical migrations.
  • Collaborate with stakeholders to identify and agree on migration business requirements.
  • Manage activities related to migration-related Incident Management, Change Management.
  • Support the forecasting of internal resource allocations.
  • Execute the vendor oversight plan.
  • Provide support for inspections/audits.
Requirements:
  • Advanced degree or a combination of Bachelor's degree in information or life sciences/healthcare and relevant industry experience.
  • Minimum of 6 years working in Pharmaceuticals, Life sciences, and Clinical Research with specific experience in leading clinical document management, TMF and/or records & information management technical migration.
  • Minimum of 5 years of full-scale technical migrations of clinical documents, particularly eTMF.
  • At least 2 major experiences in Veeva Vault related technical migrations.
  • Prior experience and knowledge of Trial Master File (TMF) reference model.
  • Prior experience in Electronic Document Management systems, specifically in Clinical and Regulatory (e.g. Veeva Clinical vault, RIM, Documentum D2LS).
  • Deep knowledge of Agile working methodologies.
  • Strong influencing and presentation skills. Ability to communicate effectively at all levels.
Desired Skills:
  • Clinical document management technical migration.
  • Budget Management.
  • Clinical Trials.
  • Coaching.
  • Data Analysis.
  • Data Integrity.
  • Learning Design.
  • Lifesciences.
  • Risk Monitoring.
  • Trends Analysis.
  • Veeva Vault.
  • TMF.

Why this role?

This is an exciting opportunity to lead the development and implementation of clinical document management strategies, working closely with stakeholders to ensure alignment with business, compliance, and operational requirements.

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